Clinical Operations Lead, Real World Late Phase

Clinical Operations Lead, based in LATAM

Job Overview:

Independently direct the execution of the Site & Patient Services (SPS) components of Real World Evidence (RWE) studies by applying clinical research experience and decision making skills to proactively set goals and tangible expectations for SPS project team members.

Essential Functions:

• Oversee the delivery of Site Management project tasks, providing advice and guidance to achieve high performance and quality project deliverables.

• Ensure overall project efficiency and adherence to project timelines and financial goals; report metrics and out of scope activities.

• Develop, implement, and maintain the SPS Operations and SPS Risk Management Plan within the agreed project strategy.

• Manage virtual teams and coordinate start-up processes to achieve SSU completion within the required timelines

• Collaborates with the Site Management Team to provide centralized site support, communication, and coordination, to assure accurate and timely completion of all contracted activities.

• Collaborate with other functional groups within the company such as data management, quality assurance and biostatistics where necessary to support milestone achievement and to manage study issues and obstacles.

Minimal requirements:

• Bachelor's degree in a health care or other scientific discipline with around 4 years clinical research/monitoring experience; or equivalent combination of education, training and experience.

• Strong written and verbal communication skills including good command of English language.

• Demonstrated team leadership.

• In depth knowledge of, and skill in applying clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

• Skill in understanding and executing complex study designs.

• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.

• Excellent planning, organizational and problem-solving skills.

• Ability to manage competing priorities and ensure on-time, high quality delivery of Project.

What we offer:

• Home based position

• Location: Argentina, Brazil, Mexico, Chile, Colombia, any city.

• Late phase studies

• Global exposure and the opportunity to learn and grow professionally

• Career opportunities to keep growing and developing your career